Urofollitropin

Registered South African indications:

• Infertility

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding
• Tumours of the pituitary or hypothalamic glands
• Ovarian, uterine or mammary carcinoma
• Gynaecological haemorrhage of unknown aetiology
• Primary ovarian failure
• Ovarian cysts or enlarged ovaries not due to polycystic ovarian disease
• Malformation of sexual organs incompatible with pregnancy
• Fibroid tumours of the uterus incompatible with pregnancy

Cautions

• Renal impairment
• Hepatic impairment
• Hypothyroidism
• Adrenocortical deficiency
• Hyperprolactinemia 
• Polycystic ovarian disease
• History of tubal disease 
• Multiple drug regimens for infertility treatment
• Risk factors for thromboembolic events

Forms avail. in SA and covered in this monograph: inj

Infertility
- Anovulation in women who have been unresponsive to other treatment

• SC: Initial (within the first 7 days of menstrual cycle): 75 IU, dly for 7 days; Titrate by 37.5 IU at intervals of 7 days; Max: 225 IU/24hrs

If a patient fails to respond adequately after 4 weeks of treatment, that cycle should be abandoned

- Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies, gamete intra-fallopian transfer and intracytoplasmic sperm injection

• SC: Initial: 150-225 IU, dly for at least the first 5 days of treatment; Titrate by 150 IU; Max: 450 IU/24hrs; Treatment duration: 12 days

Initiate 2 weeks after the start of agonist treatment

Initiate under specialist supervision

Administered immediately after reconstitution

Not indicated for use in children

Pregnancy

• FDA Pregnancy Category X

Breastfeeding

• Contraindicated

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• Not indicated for use in geriatric patients

Central Nervous System Disorders

• Headache

Cardiovascular Disorders

• Hot flushes

Respiratory Disorders

• Nasopharyngitis

Gastrointestinal Disorders

• Abdominal pain
• Nausea and vomiting
• Abdominal distension
• Abdominal discomfort
• Diarrhoea
• Constipation

Genitourinary Disorders

• Urinary tract infection
• Vaginal haemorrhage
• Ovarian hyperstimulation syndrome 
• Pelvic pain
• Breast tenderness
• Vaginal discharge

Musculoskeletal Disorders

• Muscle spasms

Skin and Subcutaneous Tissue Disorders

• Rash
• Injection site pain

No information available

• Ultrasound
• Oestradiol levels
• Luitinizing hormone levels
• Basal body temperature
• Progesterone levels
• Signs and symptoms of ovarian hyperstimulation syndrome

Urofollitropin is a preparation of highly purified follicle-stimulating hormone (FSH) extracted from the urine of postmenopausal women. Follitropins stimulate ovarian follicular growth in women who do not have primary ovarian failure. FSH is required for normal follicular growth, maturation, gonadal steroid production, and spermatogenesis.

Injection (per vial) 75iu

• Bravelle (Ferring) originator
• Fostimon (Delfran) originator